Implant for Augmentation of Cerebral Blood Flow Trial-1 (ImpACT-1). A single-arm feasibility study evaluating the safety and potential benefit of the Ischemic Stroke System for treatment of acute ischemic stroke

Khurana D, Kaul S, Schneider D, Csanyi A, Adam I, Ichaporia NR, Griewing B, Csiba L, Valikovics A, Puri V, Diener HC, Schwab S, Hetzel A, Bornstein N (2019)

Publication Type: Journal article

Publication year: 2019

Journal

PLoS ONE Public Library of Science

Book Volume: 14

Article Number: e0217472

Journal Issue: 7

DOI: 10.1371/journal.pone.0217472

Abstract

BACKGROUND: The Ischemic Stroke System is a novel device designed to deliver stimulation to the sphenopalatine ganglion(SPG).The SPG sends parasympathetic innervations to the anterior cerebral circulation. In rat stroke models, SPG stimulation results in increased cerebral blood flow, reduced infarct volume, protects the blood brain barrier, and improved neurological outcome. We present here the results of a prospective, multinational, single-arm, feasibility study designed to assess the safety, tolerability, and potential benefit of SPG stimulation inpatients with acute ischemic stroke(AIS). METHODS: Patients with anterior AIS, baseline NIHSS 7-20 and ability to initiate treatment within 24h from stroke onset, were implanted and treated with the SPG stimulation. Patients were followed up for 90 days. Effect was assessed by comparing the patient outcome to a matched population from the NINDS rt-PA trial placebo patients. RESULTS: Ninety-eight patients were enrolled (mean age 57years, mean baseline NIHSS 12 and mean treatment time from stroke onset 19h). The observed mortality rate(12.2%), serious adverse events (SAE)incidence(23.5%) and nature of SAE were within the expected range for the population. The modified intention to treat cohort consisted of 84 patients who were compared to matched patients from the NINDS placebo arm. Patients treated with SPG stimulation had an average mRS lower by 0.76 than the historical controls(CMH test p = 0.001). CONCLUSION: The implantation procedure and the SPG stimulation, initiated within 24hr from stroke onset, are feasible, safe, and tolerable. The results call for a follow-up randomized trial (funded by BrainsGate; clinicaltrials.gov number, NCT03733236).

Authors with CRIS profile

Stefan Schwab Lehrstuhl für Neurologie

Involved external institutions

Nizam's Institute of Medical Sciences IN India (IN) University of Debrecen / Debreceni Egyetem HU Hungary (HU) GB Govind Ballabh Pant Institute of Postgraduate Medical Education & Research IN India (IN) Albert-Ludwigs-Universität Freiburg DE Germany (DE) Petz Aladár County Teaching Hospital HU Hungary (HU) Neurologische Klinik Bad Neustadt an der Saale DE Germany (DE) Universität Leipzig DE Germany (DE) Jehangir Hospital IN India (IN) Borsod-Abaúj-Zemplén County Teaching Hospital HU Hungary (HU) Universitätsklinikum Essen DE Germany (DE) Tel Aviv Sourasky Medical Center / Ichilov Hospital IL Israel (IL) Postgraduate Institute of Medical Education and Research IN India (IN)

How to cite

APA:

Khurana, D., Kaul, S., Schneider, D., Csanyi, A., Adam, I., Ichaporia, N.R.,... Bornstein, N. (2019). Implant for Augmentation of Cerebral Blood Flow Trial-1 (ImpACT-1). A single-arm feasibility study evaluating the safety and potential benefit of the Ischemic Stroke System for treatment of acute ischemic stroke. PLoS ONE, 14(7). https://dx.doi.org/10.1371/journal.pone.0217472

MLA:

Khurana, Dheeraj, et al. "Implant for Augmentation of Cerebral Blood Flow Trial-1 (ImpACT-1). A single-arm feasibility study evaluating the safety and potential benefit of the Ischemic Stroke System for treatment of acute ischemic stroke." PLoS ONE 14.7 (2019).

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